check_circleStudy Completed

Endometriosis

Bayer Identifier:
16108
ClinicalTrials.gov Identifier:
NCT01595724
EudraCT Number:
Not Available
EU CT Number:
Not Available
Daily practice treatment and Influence of Visanne on the patient assessment of quality of life

Trial purpose

The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d) on the Endometriosis related quality of life. These data will be collected using a special patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to describe the basic disease status and demographic characteristics of patients searching treatment by a gynecologist because of their endometriosis. In addition, the study will give insight into the typical diagnostic measures the physicians in different countries are using in the field of endometriosis.

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - Female patients older than 18 years of age
    - Clinical or laparoscopic diagnosis of endometriosis
    - Having endometriosis related pain as leading symptom
    - Decision taken by physician to prescribe Visanne
    - Signed Informed Consent Form


  • - Contraindications listed in the local summary of product characteristics (SPC) have to be considered.

Trial summary

Enrollment Goal
3006
Trial Dates
May 2012 - May 2015
Phase
N/A
Could I Receive a placebo
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Russia
Completed
Many Locations, Ukraine
Completed
Many Locations, Belarus
Completed
Many Locations, Kazakhstan
Completed
Many Locations, Egypt
Completed
Many Locations, Kuwait
Completed
Many Locations, Saudi Arabia
Completed
Many Locations, Jordan
Completed
Many Locations, Lebanon
Completed
Many Locations, Qatar
Completed
Many Locations, United Arab Emirates

Primary Outcome

  • Percentage of patients, who show an improvement of the EHP-5 items
    date_rangeTime Frame:
    after 6 months of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Mean changes of EHP-5 items by using scores for pre-defined categories
    date_rangeTime Frame:
    after 6 months of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Patient reported severity of endometriosis related pain
    date_rangeTime Frame:
    Baseline and after 6 months of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Reasons for treatment discontinuation
    date_rangeTime Frame:
    after 6 months of treatment
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    Safety Issue:
    No
  • Safety variables will be summarized using descriptive statistics based on adverse events collection
    date_rangeTime Frame:
    after 6 months of treatment
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    Safety Issue:
    Yes

Trial design

Study to characterize patients treated with Visanne for their Endometriosis under real-life practice conditions and evaluate their quality of life at baseline and after 6 months of treatment with Visanne.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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